EP2001364A1 - Système médical pour surveiller et localiser les fils d'électrodes dans le coeur - Google Patents

Système médical pour surveiller et localiser les fils d'électrodes dans le coeur

Info

Publication number
EP2001364A1
EP2001364A1 EP06717065A EP06717065A EP2001364A1 EP 2001364 A1 EP2001364 A1 EP 2001364A1 EP 06717065 A EP06717065 A EP 06717065A EP 06717065 A EP06717065 A EP 06717065A EP 2001364 A1 EP2001364 A1 EP 2001364A1
Authority
EP
European Patent Office
Prior art keywords
electrodes
heart
medical system
electrode
electric field
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP06717065A
Other languages
German (de)
English (en)
Other versions
EP2001364A4 (fr
EP2001364B1 (fr
Inventor
Sven-Erik Hedberg
Kenth Nilsson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
St Jude Medical AB
Original Assignee
St Jude Medical AB
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by St Jude Medical AB filed Critical St Jude Medical AB
Publication of EP2001364A1 publication Critical patent/EP2001364A1/fr
Publication of EP2001364A4 publication Critical patent/EP2001364A4/fr
Application granted granted Critical
Publication of EP2001364B1 publication Critical patent/EP2001364B1/fr
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/37Monitoring; Protecting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/365Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/368Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046Tracking techniques
    • A61B2034/2051Electromagnetic tracking systems
    • A61B2034/2053Tracking an applied voltage gradient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/365Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/368Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
    • A61N1/3682Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions with a variable atrioventricular delay
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/365Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/368Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
    • A61N1/3684Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions for stimulating the heart at multiple sites of the ventricle or the atrium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/365Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/368Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
    • A61N1/3684Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions for stimulating the heart at multiple sites of the ventricle or the atrium
    • A61N1/36843Bi-ventricular stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/37Monitoring; Protecting
    • A61N1/3702Physiological parameters
    • A61N1/3704Circuits specially adapted therefor, e.g. for sensitivity control

Definitions

  • the present invention relates to a medical system according to the preamble of the independent claim.
  • the present invention is applicable to obtain information about hemodynamic heart activity, e.g. related to heart wall movements, heart wall thickening or valve plane movement. This obtained information is then used to improve the setting of an implantable heart stimulator.
  • the present invention is in particular applicable to identify optimal settings of AV- and/or VV-delays in an implantable heart stimulator, and to identify optimal electrode positions within the heart and in the coronary heart vessels.
  • the invention may be used both during implantation procedures and at follow-up procedures.
  • AV- and VV-delay are important hemodynamic parameters that need to be individually set for every patient and electrode position.
  • the optimal settings of AV- and VV-delay need feedback from data disclosing the hemodynamic status at different AV/VV ⁇ delay settings. This can be performed by measuring the blood flow in the heart with e.g. ultrasound equipment. However, such equipment is normally not available during implantation of pacemakers and implantable cardioverters/defibrillators (ICDs).
  • the main objects of the present invention are to obtain information that may be used a) to optimize time intervals of an implantable heart stimulating device, e.g. the AV-/VV- intervals; and b) to identify optimal positions for heart electrodes, preferably during the implantation procedure.
  • the present invention is based upon a system similar to the above-mentioned system from Endocardial Solutions.
  • the system according to the present invention may be a part of, or may be connected to, a programmer for a pacemaker or an ICD to be used in connection with implantation of a pacemaker or an ICD system, or during follow-up procedures of such devices.
  • the device may be a incorporated in a pacemaker or an ICD system.
  • the present invention is especially applicable to a situation when leads and catheters are to be inserted or applied to the heart.
  • External patches attached to thorax of a patient with an implanted pacemaker/ICD system may be used in the same way as described above. Measuring voltages will be applied between pairs of patch electrodes.
  • the implanted system is provided with circuitry capable of amplifying the voltages induced by the measurement current in body tissue between the pacemaker electrodes and to transmit these data to an external unit, in real time or later via data stored in the unit.
  • the external patches for obtaining orthogonal electric fields measurements between the pacemaker can and the implanted electrodes will be achieved, unless electrodes are positioned in thorax for the purpose of collecting signals from more than the pacemaker can - lead electrode vector orientation.
  • This vector orientation may be used for comparative measurements over time.
  • the three patch electrode pairs are used to detect the voltage differences in each electric field direction, i.e. the projection of the potential difference in each direction.
  • the first measurement is preferably performed during implantation and then at each follow-up.
  • a gradually decreasing contractility could be followed by the measurements of the voltage variations projected on the can/electrode vector.
  • the time switching, multiplexing, of the electric fields may be used also here. There may however be a delay between sensed signals and corresponding data sent out to the external unit. This may be overcome by registering of signals for one field orientation at a time for at least a whole heart cycle. Pattern recognition may then be applied to identify which multiplexing phase that belongs to which electric field.
  • the electric field(s) is/are being created within the body of the person carrying a device according to the present invention.
  • Figure 1 schematically illustrates an arrangement of electric field generating electrodes, applicable in the present invention.
  • Figure 2 shows a simplified block diagram of a medical system according to the present invention.
  • Figure 3 shows a block diagram of the medical system according to the present invention.
  • FIG. 4 shows a more detailed block diagram of the medical system according to the present invention.
  • Figure 5 shows a block diagram of a second preferred embodiment of the present invention.
  • Figure 6 shows a block diagram of an alternative embodiment of the present invention.
  • FIG. 7 shows a principal set-up of another alternative embodiment of the present invention.
  • similar or the same features have the same references signs in all figures.
  • Figure 1 shows how the patches may be arranged to setup three orthogonal electrical fields, and also an alternating voltage applied between pairs of patches.
  • the pacemaker leads are not shown in figure 1.
  • Figure 2 shows a simplified block diagram of a medical system according to the present invention.
  • the system further comprises a signal receiving means 8 adapted to receive a signal representing the voltage potential difference between the voltage potential of at least one of the heart electrodes used as detecting electrode and the voltage potential at a reference electrode.
  • the voltage potential is related to the generated electric field.
  • the signal receiving means 8 then generates a potential difference signal that is applied to a signal controlling and processing means 10 adapted to process the detected potential difference signal in order to determine parameters representing heart activity.
  • the excitation means 6 includes a first switching means to perform, under the control of the controlling and processing means, a switching between electrode pairs such that the generated electrical fields from different electrode pairs are generated separate from each other.
  • the signal receiving means includes a second switching means (see figures 3 and 4) adapted to perform, also under the control of the controlling and processing means, a switching in synchronism with the switching of the first switching means such that a correlation between the received voltage potential difference signal and the respective electric field generating electrode pair is achieved.
  • more than one of the heart electrodes may be used as detecting electrode.
  • a further switching means (not shown) is arranged to switch, under the control of the controlling and processing means, between the different detecting electrodes when each of the electric field generating electrode pair is active. In particular this may be advantageous during measurements of movements of the heart valve plane.
  • the alternating voltage applied to the electric field generating electrodes are sequentially distributed to the three pairs of surface electrodes and the alternating voltage preferably has a square wave pulse form and a frequency in the interval 1-10 kHz.
  • a person skilled in the art is naturally aware of other appropriate pulse forms, e.g. a sinus shaped pulse form, that may be used.
  • the signal receiving means is adapted to be directly connected to the electrode lead(s) of the heart stimulator and/or to the heart stimulator and is then adapted to receive signals from electrodes at the electrode lead(s) and also to receive signals from an electrode surface at the heart stimulator housing.
  • the voltage potential difference sensed by the heart stimulator electrodes instead are wirelessly transferred from the implantable stimulator to the signal receiving means using conventional telemetry technique.
  • the signal receiving means includes sample and hold circuits activated in dependence of the generated alternating voltages to generate a slowly varying signal representing the movement of the detecting electrode.
  • an amplifier is connected to the electrode leads that will acquire the resulting signals, caused by the electric fields within the body and by the tissue movements. Since alternating voltages have been used, the resulting signal is a modulated alternating signal that needs to be demodulated in order to obtain the signals, which carry information about heart wall movements.
  • This task will be performed by the signal processing and AfD conversion means (see figure 3).
  • the above-mentioned two means 6, 8 are controlled by the control means 10, that preferably includes a microprocessor.
  • the control means will control when the switches of the voltage generators will be connected to respective patch pair.
  • the microprocessor will also receive the A/D-converted data from the signal receiving means 8, and will thus know from which patch pair the actual signal emanates. In that way the signals, designated X, Y and Z in figure 3, which represent the information about e.g. heart wall movements, will be identified. That information will then be used e.g. to perform AV-delay optimization, that e.g. may be achieved by the microprocessor in the control means.
  • a detailed block diagram of the device is illustrated.
  • a square wave voltage generator in the excitation means 6 that is the source for the generation of the three electric fields inside the body. It typically has a frequency of a couple of kHz, preferably 10 kHz.
  • the voltage will be sequentially distributed to the three pairs of patches by a multiplexer, which switching is controlled by the control means.
  • each patch pair, in a three patch pair system will be active during approximately 3 ms and a total cycle for exciting all three patch pairs is then 9 ms.
  • the 10 kHz excitation frequency results in 30 periods per each 3 ms activation slot of a patch pair.
  • An electrode of a pacemaker lead inside the body will collect potentials which are directly correlated with the square wave voltage and the movements of the electrodes of the lead.
  • the signals from the lead will show a square wave shape modulated by electrode movements and switching of the electric fields.
  • the lead signals will be fed to a multiplexer, which switching is in synchronism with the switching of the electric fields. In that way signals from respective electric field direction are separated.
  • the signals are applied to the input of three sample and hold circuits in the signal receiving means 8. The nature of the signals are still square wave shaped. The transfer to a slowly varying signal is accomplished by activating each sample and hold circuit synchronously with the square wave voltage.
  • Correct gating of the square wave voltage signal is accomplished by AND-gates receiving information on which electric field is active at each time.
  • Each sample and hold circuit is connected to an analog and digital converter.
  • the control means is preferably embodied by the microprocessor ( ⁇ m). The microprocessor will then control the electric field multiplexer since it includes information regarding which electric field is active and also from which A/D-converter appropriate information may be received.
  • the microprocessor then receives information of how the electrodes move inside the body.
  • the electrodes are normally attached to the heart walls and will thus follow the movements of those. This may be further utilized by the microprocessor for varying parameters of the pacemaker/ICD, which will result in different heart muscle activities.
  • the movement of the heart muscle may be obtained in that way. If the electrodes are placed in such a way that they deliver signals which will be representative of heart wall contractions the microprocessor may carry out a test by varying, e.g. the AV-delay, and simultaneously notice which delay resulted in the most favourable heart wall movement.
  • VV-delay and stimulation rate Other parameters may be VV-delay and stimulation rate.
  • FIG. 5 shows a schematic block diagram of another preferred embodiment of the present invention especially applicable at follow-up procedures.
  • the detected voltage potential difference is wirelessly communicated from the implantable unit, using e.g. conventional telemetry, to the external medical system.
  • the function of the external medical system (external equipment) in figure 5 is the same as in the system described above in connection with figure 4.
  • Figure 6 shows a schematic block diagram of an alternative embodiment of the present invention that illustrates the detection and identification of the three electric fields that are necessary for demodulation of the square wave signal, e.g. for obtaining heart wall movements.
  • the reconstruction of the square wave from the raw signals obtained from inside the patient is improved by using a band-pass filter enhancing the known frequency of the square wave.
  • Phase-locked loops are circuits known to perform such actions.
  • the identification of the electric fields may be performed in a number of ways, by giving each field a unique signal pattern, e.g. by inserting a short period at the end of each period of each field that may leave an empty space during which no square waves are delivered. This may start a test period, during which the pulse pattern of the next square waves will be correlated with a pre-known pattern, unique for each field. The identification of each electric field will therefore be delayed.
  • the reconstructed square wave and the raw signals must be delayed to the same degree. In this way all necessary signals are at hand for obtaining the heart wall movement signals as have been presented in relation with the other embodiments.
  • the detecting electrode and the reference electrode are separate from the electric field generating electrodes. It is naturally also possible to use one or many of the electrodes of the electric field generating electrodes as reference electrode. A person skilled in the art would easily arrange a multiplexing circuitry to make the necessary connections in order to use one of those electrodes as a reference electrode.
  • only one electrode pair is used to create the electric field and in this embodiment the electric field is created between two implanted electrodes, e.g. between an electrode 20 at the stimulator housing 22 and a ventricular tip electrode 24 positioned in the lower part of the right ventricle.
  • the detection electrode may then be e.g. a coronary sinus electrode 26 arranged between the housing and the ventricular tip electrode.
  • the potential difference signal obtained by such an invasive set-up, measured between the detection electrode and a ventricular ring electrode 28 being the reference electrode, may then, after an appropriate processing, be used to monitor the movement of the valve plane.
  • an LV lead is positioned in a coronary vein on e.g. the left lateral heart wall. Another lead is placed in the right ventricle.
  • an atrial lead may also be present.
  • the leads are arranged such that their electrodes will follow the movements of the heart walls. This may be accomplished by screwing the RV-lead into the free RV-wall or septum or by creating a loop inside the right ventricle making the ring - electrode pressing against the wall.
  • An alternative way is obtained by inserting a pre-bent stylet into the lead forcing the ring- electrode to adhere to the wall.
  • Stimulation pulses will be applied to the stimulating electrodes in the heart separated by different AV- and/or VV-delays as is common practise in the art.
  • the left and right heart wall movements will then be tracked and observed using the system according to the present invention.
  • the AV- and VV-delay settings may now be changed and set to optimal values by the physician according to gained experience of the timings that result in optimal hemodynamics.
  • a simplified way to perform this is to change AV/VV-delays in order to get simultaneous wall movements.
  • the positions of the stimulating electrodes may have a large impact on the hemodynamic performance.
  • a change in stimulating electrode position may demand another VV-delay for optimal pacing. The physician should therefore test different delays for different stimulating sites.
  • the contractility is influenced both by AV- and VV-delays, and may thus also be used for optimal settings of those parameters.
  • the movement of the heart walls during VV-pacing may vary from one position to another. In many cases synchronized RV- and LV-contractions result in maximum contractility or maximum heart muscle movements.
  • the measurements of heart wall movements according to this invention may be applied in this situation. With electric fields from external patches, heart wall movements in three directions may be obtained. The movement data will be picked up from the point in time where the most forceful contractions occur.
  • the three movement components can be processed in different ways and with varying degrees of computational demands. It may be sufficient to just pick one of them or use the sum. If needed and if the computational resources are at hand, the vector sum of the three vectors may be calculated.
  • VV-delay The optimum VV-delay will be found by bi-ventricular stimulation, stepping through a range of VV-delays under observation of heart wall movements and picking the highest value. In a one dimensional movement direction the reliability of the measurement is lower, but the same procedures still apply.
  • the period of interest starts with the stimulation pulse(s) and ends after about 100-200 ms.
  • ECG pre-ejection period
  • LVET Left ventricular ejection time
  • EMS electromechanical systole

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physiology (AREA)
  • Biophysics (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention concerne un système médical à utiliser en relation avec un stimulateur cardiaque implantable doté d'électrodes cardiaques de détection et de stimulation. Le système comprend un nombre prédéterminé de paires d'électrodes (4), par exemple trois électrodes à pièce de contact à agencer sur ou à l'intérieur d'un être humain ou d'un animal de telle sorte qu'un champ électrique à travers le cœur est généré entre les électrodes d'une paire d'électrodes respective. Le ou les champs électriques sont adaptés pour être générés par un moyen d'excitation (6), comprenant des générateurs de tension d'excitation de champs électriques, connectés aux électrodes, par l'application de tensions alternatives à une fréquence prédéfinie sur les électrodes de la ou les paires d'électrodes. Le système comprend un moyen de réception de signal (8) adapté pour recevoir un signal représentant la différence de potentiel de tension entre le potentiel de tension au niveau d'une des électrodes cardiaques utilisée comme une électrode de détection et une électrode de référence, le potentiel de tension étant lié au champ électrique généré. Le moyen de réception de signal génère ensuite un signal de différence de potentiel qui est appliqué à un moyen de traitement et de régulation de signal (10) adapté pour traiter le signal de différence de potentiel détecté afin de déterminer des paramètres représentant l'activité cardiaque.
EP06717065.4A 2006-03-27 2006-03-27 Système médical pour déterminer les réglages optimaux des délais av, vv ou la fréquence de stimulation d'un stimulateur cardiaque implantable Not-in-force EP2001364B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/SE2006/000384 WO2007111542A1 (fr) 2006-03-27 2006-03-27 Système médical pour surveiller et localiser les fils d'électrodes dans le cœur

Publications (3)

Publication Number Publication Date
EP2001364A1 true EP2001364A1 (fr) 2008-12-17
EP2001364A4 EP2001364A4 (fr) 2010-06-02
EP2001364B1 EP2001364B1 (fr) 2015-02-25

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP06717065.4A Not-in-force EP2001364B1 (fr) 2006-03-27 2006-03-27 Système médical pour déterminer les réglages optimaux des délais av, vv ou la fréquence de stimulation d'un stimulateur cardiaque implantable

Country Status (3)

Country Link
US (1) US7908005B2 (fr)
EP (1) EP2001364B1 (fr)
WO (1) WO2007111542A1 (fr)

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US8532734B2 (en) 2008-04-18 2013-09-10 Regents Of The University Of Minnesota Method and apparatus for mapping a structure
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US8019409B2 (en) 2008-06-09 2011-09-13 Pacesetter, Inc. Cardiac resynchronization therapy optimization using electromechanical delay from realtime electrode motion tracking
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US7908005B2 (en) 2011-03-15
WO2007111542A8 (fr) 2008-09-12
EP2001364A4 (fr) 2010-06-02
WO2007111542A1 (fr) 2007-10-04
EP2001364B1 (fr) 2015-02-25
US20090287269A1 (en) 2009-11-19

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